(331 days)
The MultiPulse HoPLUS Laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
The MultiPulse HoPLUS Laser system and its fiber optic delivery system is a laser Class IV, pulsed, solid state Holmium-YAG, which emits laser radiation with a wavelength of approximately 2100 nm with a pulse with between 150-1700 microseconds. The laser power up to 140 Watts is transmitted to the tissue through different optical fibers. The laser system consists of: Laser system including control panel (user interface) Foot switch A variety of application fibers and accessories
The provided text is a 510(k) summary for the Asclepion Laser Technologies GmbH MultiPulse HoPLUS. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.
However, the document does not contain information about specific acceptance criteria for performance, a study to prove the device meets those criteria, or details regarding sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies.
The document states:
- Non-clinical Performance Data: "Verification and Validation activities. These activities comprises the verification and validation of the software, the verification of the device, the verification of the fiber, the verification of the laser, an Investigation Report and the Final Test Report. These investigations lead to the conclusion, that the device is as safe and effective as the predicates and no additional risks occur."
- Clinical Performance Data: "None"
Therefore, based on the provided text, I cannot complete most of the requested information. The device's substantial equivalence is based on non-clinical performance data (verification and validation) and comparison to predicate devices, not on a specific clinical study with defined acceptance criteria and human expert evaluation in the way requested.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.